• What Makes This Role Exciting
• In this position, you'll have the opportunity to: + Lead and support critical
• sterilization and microbiological validation activities
• + Develop additional expertise with
• gamma and electron-beam sterilization
• + Act as a technical resource for microbiology and new-product initiatives + Work closely with Quality, Manufacturing, Engineering, and other teams + Participate in contamination-control and environmental-monitoring programs + Contribute to investigations, CAPAs, and continuous improvement initiatives + Gain exposure to both
• internal audits and external regulatory inspections
• + Make a direct contribution to product quality, compliance, and patient safety
• Key Responsibilities
• As a Microbiologist II, you will perform and oversee a variety of laboratory and quality activities, including: + Conduct microbiological testing such as
• bioburden, endotoxin, sterility, growth promotion, cell culture, and environmental monitoring
• + Perform microbiological method validations for medical and non-medical devices + Lead and support sterilization validation activities in accordance with

• ISO 11137

• + Participate in
• dose audits, dose-setting studies, dose mapping, and sterilization requalification
• + Evaluate sterilization results and identify or escalate trends requiring further investigation + Support the development and ongoing improvement of
• contamination-control and facility-monitoring programs
• + Assist with facility gowning requirements and programs + Serve as a microbiology resource and
• subject matter expert (SME)
• for new-product activities + Prepare and maintain
• SOPs, laboratory procedures, validation protocols, and technical reports
• + Review and trend microbiological laboratory data for quality and management reporting + Perform testing on returned or nonconforming products in support of investigations and complaint resolution + Participate in deviation investigations, root-cause analysis, and
• CAPA activities
• + Work cross-functionally to resolve microbiological and product-quality concerns + Support internal quality audits and external regulatory inspections + Provide training related to
• aseptic technique, hygiene requirements, and microbiological practices
• + Coordinate specialized testing with outside and third-party laboratories + Maintain appropriate laboratory inventory, equipment, supplies, and consumables + Use
• SAP•to support purchase requisitions and material-transfer activities •What We're Looking For•The ideal candidate will bring a strong foundation in microbiology along with experience working within a regulated laboratory environment.

• Qualifications include:
• + Bachelor's or master's degree in
• Microbiology or a related scientific discipline
• + Minimum of
• 3 years of relevant experience in a GMP-regulated laboratory environment
• + Medical device, pharmaceutical, life sciences, or comparable regulated-industry experience preferred + Experience or working knowledge of
• gamma and electron-beam sterilization
• + Knowledge of
• ISO 13485 and

ISO 11137

• + Understanding of medical-device regulations and applicable quality requirements + Experience with microbiological testing, validation, and laboratory documentation + Strong technical-writing, analytical, investigation, and problem-solving abilities + Proficiency with Microsoft Word, Excel, Outlook, and laboratory-based computer systems + Ability to independently manage responsibilities while collaborating effectively with cross-functional teams •Benefits•We offer a competitive total rewards package that includes: + •Competitive compensation•+ •Medical insurance•+ •Paid time off•in accordance with company policy + •401(k) with a 5% company match•Ready for Your Next Opportunity?
• If you have a strong microbiology background and are ready to expand your involvement in
• sterilization validation, method validation, contamination control, and quality improvement
• , we'd like to hear from you. This is an opportunity to apply your technical expertise in a role where your work directly influences
• product quality, regulatory compliance, and patient safety

• Apply today to learn more about the Microbiologist II opportunity in Monroe, North Carolina.

• Pay Details:

• $60,000.

• Massachusetts Candidates Only:

• It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.